CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
ribavirin pre-treatmentdrug
Likely dose
ribavirin pre-treatment 10,4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00993122
NCT00993122Phase 4Completed
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Phase 2 Randomized Multicenter Controlled Study of Ribavirin Pre-treatment (8 Weeks) Followed by Standard Therapy With Ribavirin and Pegylated Interferon (48 Weeks) in Transplanted Patients With Recurrence of Chronic Hepatitis C

University of Roma La Sapienza·interventional·Posted Oct 12, 2009·Updated Jun 22, 2015

In Brief

A Phase 4 clinical trial evaluating ribavirin pre-treatment for Hepatitis C. Completed, enrolled 100 participants across 1 site.

Detailed Summary

The results of antiviral therapy in patients with recurrent hepatitis C after liver transplantation are lower than standard. Ribavirin has immune-modulating effects and seems to be crucial to optimize viral treatment. The aim of this multicenter controlled study is to examine the effect of Ribavirin pre-treatment preceding the combination therapy with peginterferon plus ribavirin on the sustained virological response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2009
Enrollment StartOct 1, 2009
Primary CompletionApr 1, 2010
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.7 years ago

Interventions

ribavirin pre-treatmentdrug

patients receive ribavirin (10,4 mg/kg/day) and pegylated interferon alfa-2b (1,5 mcg/kg/week).Pre-treatment arm will receive a 8-week monotherapy treatment with only ribavirin (same dosage) and the controlled arm will receive 48 week of standard combined therapy (ribavirin plus pegylated interferon)